ASPIRIN- aspirin tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain Reliever/Fever Reducer temporarily relieves • headache • toothache • minor pain of arthritis • muscle pain • pain and fever of colds • menstrual pain

Authorization status:

OTC monograph final

Summary of Product characteristics

ASPIRIN- ASPIRIN TABLET, COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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ASPIRIN 325MG
ACTIVE INGREDIENT (IN EACH TABLET)
Aspirin 325mg (NSAID*)
*nonsteriodal anti-flammatory drug
PURPOS E
Pain Reliever/Fever Reducer
US ES
temporarily relieves
• headache
• toothache
• minor pain of arthritis
• muscle pain
• pain and fever of colds
• menstrual pain
WARNINGS
REYE'S SYNDROME: Children and teenagers who have or are recovering
from chicken pox or flu-like
symptoms should not use this product. When using this product, if
changes in behavior with nausea and
vomiting occur, consult a doctor because these symptoms could be an
early sign of Reye's Syndrome, a
rare but serious illness.
ALLERGY ALERT: Aspirin may cause a severe allergic reaction which may
include
• hives
• facial swelling
• shock
• asthma(wheezing)
STOMACH BLEEDING WARNING: This product contains an NSAID, which may
cause stomach bleeding.
The chance is higher if the user:
• is age 60 or older
• has had stomach ulcers or bleeding problems
• takes a blood-thinning (anticoagulant) or steriod drug
• takes other drugs containing prescription or nonprescription
NSAIDS (aspirin,Ibuprofen, naproxen, or
others)
• takes more or for a longer time than directed
• has 3 or more alcoholic drinks every day while using this product
DO NOT USE
if you have ever had an allergic reaction to any other pain
reliever/fever reducer.
ASK A DOCTOR BEFORE USE IF
• stomach bleeding warning applies to user
• user has a history of stomach problems, such as heartburn
• user has high blood pressure, heart disease, liver cirrhosis, or
kidney disease
• user is taking a diuretic
• user has asthma
• user has not been drinking fluids
• user has lost a lot of fluid due to vomiting or diarrhea
ASK A DOCTOR OR PHARMACIST BEFORE USE IF